Phase IIb Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 on Healthy People Aged 18-65

Phase 2

Completed

• Conditions: Tuberculosis
• Interventions: Biological: 10μg/ml ESAT6-CFP10; Biological: 5μg/ml ESAT6-CFP10; Biological: placebo; Biological: BCG

• Registration Number: NCT02389322
• Lead Sponsor: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

Brief Summary

The investigators select 500 subjects who meet the standard and are considered as study population I. Do specific gamma-interferon detection before the skin test， then inject intradermally with two dosage ESAT6-CFP10 and Tuberculin purified protein derivative (TB-PPD) at different arm of the same subject and get 192 participants whose three kinds of detection result are all negative and are considered as study population II.Then,they are immune to the Bacillus Calmette-Guerin (BCG) vaccine or the placebo of the BCG. Do specific gamma-interferon detection before the skin test， then inject intradermally with two dosage ESAT6-CFP10 and TB-PPD at different arm of the same subject 12 weeks after immunity.Negative rate of ESAT6-CFP10 after vaccination BCG as the main index , evaluate the specificity of different doses of ESAT6-CFP10, and conform the optimal dose of ESAT6-CFP10.

Detailed Description

1.the correlation of three detection methods for study population I

500 study population I are randomly divided into two different dose group on average, according to ESAT6-CFP10 dose(5μg/ml or 10μg/ml). Do specific gamma-interferon(γ-IFN) detection before the skin test，then inject intradermally with 5μg/ml ESAT6-CFP10 or 10μg/ml ESAT6-CFP10 and TB-PPD at different arm of the same subject.Evaluate respectively the positive rate of three detection methods 、the correlation of three detection methods and the security of study population I after application for ESAT6-CFP10 .

2.screen study population II

Choose those participants, whose result of three detection (ESAT6-CFP10、TB-PPD andγ-IFN ) all negative, HIV negative and chest X-ray no abnormalities, into study population II.

3.study population II vaccinate BCG or placebo

Study population II ,according to the same proportion ,are randomly divided into four group in double blinded state,: 5μg/ml ESAT6-CFP10 after BCG immunization, 10μg/ml ESAT6-CFP10 after BCG immunization, 5μg/ml ESAT6-CFP10 after placebo-controlled immunization , 10μg/ml ESAT6-CFP10 after placebo-controlled immunization.They vaccinate BCG or the placebo of BCG.

4.Inject ESAT6-CFP10 12 weeks after inoculation in study population II

The investigators draw blood and operate specific gamma-interferon(γ-IFN) detection before the skin test，then inject intradermally with 5μg/ml ESAT6-CFP10 or 10μg/ml ESAT6-CFP10 (in double blinded state) and TB-PPD at different arm of the same subject ,according to the above grouping scheme.

Calculate the negative coincidence rate and the correlation of three detection methods, and observe the safety of ESAT6-CFP10 in study population II at the same time.Evaluate the specificity of different doses of ESAT6-CFP10, negative rate of ESAT6-CFP10 after vaccination BCG as the main index. And finally conform the optimal dose of ESAT6-CFP10.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-05
• Study First Submitted QC: 2015-03-16
• Study First Posted: 2015-03-17
• Primary Completion: 2015-07
• Status Verified: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2017-03-15
• Last Update Posted: 2017-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1044

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10μg/ml ESAT6-CFP10 after BCG immunization	10μg/ml ESAT6-CFP10	A within group paired comparison of 10μg/ mL ESAT6-CFP10 and TB-PPD in 48 person of study population II. The 10μg/ mL ESAT6-CFP10 and TB-PPD agents are given concomitantly to each volunteer in the right and left forearms 12 weeks after BCG immunization, according to a randomisation scheme .
5μg/ml ESAT6-CFP10 after BCG immunization	5μg/ml ESAT6-CFP10	A within group paired comparison of 5μg/ mL ESAT6-CFP10 and TB-PPD in 48 person of study population II. The 5μg/ mL ESAT6-CFP10 and TB-PPD agents are given concomitantly to each volunteer in the right and left forearms 12 weeks after BCG immunization, according to a randomisation scheme .
5μg/ml ESAT6-CFP10 after BCG immunization	BCG	A within group paired comparison of 5μg/ mL ESAT6-CFP10 and TB-PPD in 48 person of study population II. The 5μg/ mL ESAT6-CFP10 and TB-PPD agents are given concomitantly to each volunteer in the right and left forearms 12 weeks after BCG immunization, according to a randomisation scheme .
10μg/ml ESAT6-CFP10 after BCG immunization	BCG	A within group paired comparison of 10μg/ mL ESAT6-CFP10 and TB-PPD in 48 person of study population II. The 10μg/ mL ESAT6-CFP10 and TB-PPD agents are given concomitantly to each volunteer in the right and left forearms 12 weeks after BCG immunization, according to a randomisation scheme .
10μg/ml ESAT6-CFP10 after placebo immunization	placebo	A within group paired comparison of 10μg/ mL ESAT6-CFP10 and TB-PPD in 48 person of study population II. The 10μg/ mL ESAT6-CFP10 and TB-PPD agents are given concomitantly to each volunteer in the right and left forearms 12 weeks after placebo controlled immunization, according to a randomisation scheme.
5μg/ml ESAT6-CFP10 after placebo immunization	placebo	A within group paired comparison of 5μg/ mL ESAT6-CFP10 and TB-PPD in 48 person of study population II. The 5μg/ mL ESAT6-CFP10 and TB-PPD agents are given concomitantly to each volunteer in the right and left forearms 12 weeks after placebo controlled immunization, according to a randomisation scheme .

Primary Outcome Measures

Name	Time	Method
immune response of ESAT6-CFP10 from the size of induration or redness in all population	within 72 Hours After Intradermal Injection With ESAT6-CFP10	We measure the size 24h,48h,72h after administered intradermally ESAT6-CFP10
immune response of TB-PPD from the size of induration or redness in all population	within 72 Hours After Intradermal Injection With TB-PPD	We measure the size 24h,48h,72h after administered intradermally TB-PPD
the results of specificity γ-IFN test in all subjects	before administered intradermally

Secondary Outcome Measures

Name	Time	Method
ESAT6-CFP10 cosistency with γ-IFN in all subjects	within 72 hours after injection
TB-PPD cosistency with γ-IFN in all subjects	within 72 hours after injection
the Number of Participants With Adverse Events	within 72 hours after injection
ESAT6-CFP10 cosistency with TB-PPD in all subjects	within 72 hours after injection

Trial Locations

Locations (1)

Jurong Province Centers for Disease Control and Prevention; 🇨🇳 Jurong, Jiangsu, China